Recruiting

AIR

Sponsor:

Chronic Conditions Research Fund

Code:

NCT07427459

Conditions

Perimenopause

Menopausal Complaints

Eligibility Criteria

Sex: Female

Age: 38 - 60

Healthy Volunteers: Not accepted

Interventions

Amygdala and Insula Retraining (AIR)

Study Details

Brief summary:

The goal of this study is to evaluate a neuroplasticity-based mind-body intervention, Amygdala and Insula Retraining (AIR), compared to a wait-list control in individuals experiencing perimenopausal symptoms.

Our research questions include:

Does AIR reduce overall perimenopausal symptom burden compared to a wait-list control?

Does AIR improve sleep disturbance, vasomotor symptom interference, fatigue, mood, anxiety, and quality of life in perimenopausal individuals?

Are symptom changes associated with improvements in autonomic regulation and sleep parameters, as reflected by exploratory wearable measures including heart rate variability?

Conditions

Perimenopause

Menopausal Complaints

Study ID

NCT07427459

Start date

Jul 15, 2026

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 38 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Experiencing perimenopausal symptoms
  • Meets STRAW+10 criteria based on self-assessment (-2 to +1c)
  • Able to read and understand English
  • Access to internet

Exclusion Criteria:

  • Pregnancy
  • Presence of a severe psychiatric condition requiring immediate clinical intervention
  • Uncontrolled thyroid disease or prolactinoma
  • Active cancer treatment
  • Inability to provide informed consent
  • Any medical or psychiatric condition that, in the judgment of the investigator or study team, would interfere with safe participation or study completion

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amygdala insula retraining

Participants receive immediate access to the 12-week Amygdala and Insula Retraining (AIR) program in addition to treatment as usual.

no intervention: Control

Participants receive treatment as usual for 12 weeks and are offered access to the Amygdala and Insula Retraining (AIR) program after completion of the primary outcome assessment.

Interventions

Amygdala and Insula Retraining (AIR)

Mind-body brain retraining intervention

Primary outcome measure

  • Menopause Rating Scale (MRS) Total Score [ Time Frame: Baseline (Week 0) to post-intervention (Week 12) ]

Central Contacts and Locations

Locations

Luther College Department of Psychology

Recruiting

Decorah, Iowa, United States, 52101

Contacts

Loren Toussaint, Ph.D., Ph.D. in Psychology

312-768-8649kate@ccrfund.org

Kate Research Manager

312-768-8649kate@ccrfund.org

More Information

Sponsor

Chronic Conditions Research Fund

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Amygdala and Insula Retraining (AIR)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Chronic Conditions Research Fund on 2026-06-29.